Evaluation of a neuroprosthesis for improving mobility in paralyzed individuals
Evaluation of Advanced Lower Extremity Neuroprostheses
This study is testing a new device that helps people with paralysis improve their movement and balance through a special electrical stimulation system implanted in their muscles.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | Case Western Reserve University Academic / other |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Trial ID | NCT00623389 on ClinicalTrials.gov |
What this trial studies
This study evaluates a surgically implanted functional electrical stimulation (FES) system designed to enhance exercise, standing, stepping, and balance in individuals with varying degrees of paralysis. Participants will undergo surgery to implant electrodes into the muscles of the trunk and legs, which are connected to a stimulator. Following implantation, patients will receive training in mobility skills using the FES system, along with a prescribed rehabilitation program. The study includes assessments of strength, balance, and functional abilities at multiple follow-up points after discharge.
Who should consider this trial
Good fit: Ideal candidates include individuals with low cervical or thoracic spinal cord injuries or other paralyzing conditions who meet specific inclusion criteria.
Not a fit: Patients with certain medical conditions such as pacemakers, uncontrolled seizure disorders, or significant psychological issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mobility and quality of life for patients with paralysis.
How similar studies have performed: Other studies have shown promise with similar functional electrical stimulation approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Phase I Inclusion Criteria 1. Skeletal maturity and ability to sign informed consent (\>18 years) 2. Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs 3. Innervated and excitable lower extremity and trunk musculature 4. Adequate social support and stability 5. Willingness to comply with follow-up procedures Phase I Exclusion Criteria 1. Non-English speaking 2. Females who are pregnant 3. Current pressure injuries that would be exacerbated by study activities 4. Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities 5. History of spontaneous fractures or other evidence of excessively low bone density 6. History of vestibular dysfunction, balance problems, or spontaneous falls 7. Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.
Where this trial is running
Cleveland, Ohio and 1 other locations
- Louis Stokes Cleveland VA Medical Center — Cleveland, Ohio, United States (Recruiting)
- MetroHealth System — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ronald J Triolo, Ph.D. — Case Western Reserve University
- Study coordinator: Lisa M Lombardo, MPT
- Email: lisa.lombardo2@va.gov
- Phone: 216-791-3800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.